The purpose of this study is to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis.

Hospital length of stay (hours) [ Time Frame: From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of morphine equivalents per kilogram of body weight used during hospitalization [ Time Frame: Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment ] [ Designated as safety issue: No ]

Hypotension associated with infusion [ Time Frame: Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ] [ Designated as safety issue: Yes ]

Defined as >20% systolic blood pressure reduction from measurement in the outpatient clinic within the last year while well, when available, or from the median normal blood pressure for age and height

Warm sensation associated with study drug infusion [ Time Frame: Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ] [ Designated as safety issue: Yes ]

Rehospitalization [ Time Frame: Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge) ] [ Designated as safety issue: Yes ]

Development of acute chest syndrome (ACS) [ Time Frame: Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment ] [ Designated as safety issue: Yes ]

Functional outcomes and health-related quality of life (HRQL) [ Time Frame: HRQL will be assessed during the 1st study drug infusion, after the last study drug infusion, 8-10 days post discharge, and 1-3 months post discharge ] [ Designated as safety issue: No ]

40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses

Placebo Comparator: Placebo group

Drug: Normal Saline Placebo

(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Detailed Description:

It is well known that children with sickle cell disease are at risk for acute pain crises. The usual treatment for these pain crises, intravenous fluids and pain medicines such as morphine, has changed little over the past three decades. In a pilot study, the addition of intravenous magnesium to standard therapy decreased length of stay; however, this study was not randomized, not blinded, not placebo-controlled, and not adequately powered to assess safety.

We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about 208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will return for a routine clinic visit up to 3 months after discharge for a baseline assessment. Patients will also complete health-related quality of life measures at 4 timepoints throughout the study.

current oral magnesium supplementation or current enrollment in another therapeutic study protocol

previously diagnosed clinical stroke

current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline

allergy to magnesium sulfate

discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01197417